Closure device with long tines

ABSTRACT

A device for engaging tissue may include a generally annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane. The body may be movable from a substantially planar configuration lying generally in the plane towards a transverse configuration extending out of the plane. The body may include a plurality of looped elements including alternating inner and outer curved regions. The inner curved regions may define an inner periphery of the body and the outer curved regions may define an outer periphery of the body in the planar configuration. A plurality of tines may extend from the outer curved regions. The tines may be oriented generally towards the central axis in the planar configuration and generally parallel to the central axis in the transverse configuration. The tines may extend beyond the central axis without passing through the central axis so as to collectively form a central lumen about the central axis in the planar configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present disclosure relates generally to tissue closure apparatusesand methods.

2. The Relevant Technology

During intravascular and other related medical procedures, catheters aretypically inserted through an incision or puncture in the skin andunderlying tissues to access an artery or vein, typically in the groin,neck, or subclavian areas of a patient. The catheter can be insertedthrough a puncture in the blood vessel and guided to the desired site toperform interventional procedures such as angiography, angioplasty,stent delivery, plaque removal, and infusion of a therapeutic substance.

Often these procedures are performed by inserting a hollow needlethrough a patient's skin and muscle tissue into the vascular system. Aguide wire then is passed through the needle lumen into the patient'sblood vessel. The needle is removed and an introducer sheath is advancedover the guide wire into the vessel. The catheter typically is passedthrough the lumen of the introducer sheath and advanced over the guidewire into position for the medical procedure.

After the procedure is completed and the catheter and introducer sheathare removed from the patient, however, the access hole must be closed toprevent hemorrhage. This is typically achieved by applying pressure overthe blood vessel manually and then by applying a pressure bandage or acompressive weight. With conventional methods, the risk of post-puncturehemorrhage is high, which can cause considerable complications. The riskof complications is exacerbated by the concomitant use of anticoagulantmedications, such as heparin or warfarin, and by anti-platelet drugs,which are commonly used following a procedure in order to prevent clotformation and thrombus and/or to treat vascular disease.

It is generally recognized that many currently employed vascular sealingmethods and devices and other tissue closure methods and devicesincompletely seal holes or wounds in vascular or other tissue. Achievingcomplete wound closure is particularly important in sealing arterialpunctures, which are relatively high pressure systems. For example,under normal blood pressure, the arterial system has a pressure of about120/80 mmHg or more. Failure to completely close arterial holes canresult in hematoma, exsanguination, and in extreme cases, may result incatastrophic consequences, such as limb amputation and death.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to devices and methods for engagingtissue, e.g., to connect tissue segments together or to close and/orseal openings through tissue, such as in a wall of a body lumen. Moreparticularly, the present invention is directed to vascular closuredevices or clips for closing a puncture in a wall of a blood vesselformed during a diagnostic or therapeutic procedure.

In one aspect of the present invention, a device for engaging tissueincludes a generally annular-shaped body defining a plane and disposedabout a central axis extending substantially normal to the plane. Thebody may be movable from a substantially planar configuration lyinggenerally in the plane towards a transverse configuration extending outof the plane. The body may include a plurality of looped elementsincluding alternating inner and outer curved regions that define aninner and outer periphery of the body, respectively, in the planarconfiguration. A plurality of tines may extend from the outer curvedregions, and may be oriented generally towards the central axis in theplanar configuration, and substantially parallel to the central axis inthe transverse configuration.

Each tine may extend through the inner periphery in the planarconfiguration. The inner periphery may bound a central region throughwhich the central axis extends in the planar configuration, and at leastone of the tines may extend into the central region. The looped elementsof the device may bound inwardly facing cavities having a mouth boundedon either side by adjacent inner curved regions. Each tine may extendthrough a corresponding mouth.

The looped elements of the device may generally define an endless zigzagpattern, e.g., a substantially sinusoidal pattern, extending about thecentral axis. In addition, the looped elements may be expandable betweenexpanded and compressed states for increasing and reducing a peripheryof the body in the transverse orientation, respectively. The loopedelements may be biased towards one of the compressed and expandedstates.

In addition, one or more secondary tines may extend from the innercurved regions, and may be oriented generally towards and substantiallyorthogonal to the central axis in the planar configuration, andsubstantially parallel to the central axis in the transverseconfiguration. The secondary tines may have a length substantiallyshorter than the primary tines that extend from the outer curvedregions. The secondary tines may be disposed on either side of theprimary tines.

In another aspect of the present invention, a device for engaging tissueincludes a generally annular-shaped body defining a plane and disposedabout a central axis extending substantially normal to the plane. Thebody may be movable from a substantially planar configuration lyinggenerally in the plane towards a transverse configuration extending outof the plane. The body may also include a plurality of looped elementsincluding alternating inner and outer curved regions that define aninner and outer periphery of the body, respectively, in the planarconfiguration. A plurality of tines may extend from the outer curvedregions, and may be oriented generally towards the inner periphery inthe planar configuration, and substantially parallel to the central axisin the transverse configuration. The tines may extend past the centralaxis without passing through the central axis so as to form a centrallumen about the central axis in the planar configuration.

In the planar configuration, the tines may at least partially overlapand/or may extend completely through opposite sides of the innerperiphery. The looped elements of the device may bound inwardly facingcavities. The inwardly facing cavities may have a mouth bounded oneither side by adjacent inner curved regions. Each tine may extendthrough a corresponding mouth. Each tine may extend through the innerperiphery and into a corresponding inwardly facing cavity on an oppositeside of the body in the planar configuration. Each tine may be closer toone of the adjacent inner curved regions that bound the correspondingmouth than to the other of the adjacent inner curved regions that boundthe corresponding mouth.

The looped elements of the device may generally define an endless zigzagpattern, e.g., a substantially sinusoidal pattern, extending about thecentral axis. The zigzag pattern may be asymmetrical.

In addition, one or more secondary tines may extend from the innercurved regions, and may be oriented generally towards and substantiallyorthogonal to the central axis in the planar configuration, andsubstantially parallel to the central axis in the transverseconfiguration. The secondary tines may have a length substantiallyshorter than the tines that extend from the outer curved regions. Thesecondary tines may be disposed on either side of the primary tines.

Embodiments of the present invention may provide several advantages overconventional designs. For example, embodiments of a closure deviceaccording to the present invention may provide an improved, morecomplete closure of a vessel opening than prior designs. Furthermore,embodiments of a closure device according to the present invention maybe less likely to snag a guide wire when installed. Other advantages mayalso be provided by the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. In the drawings,like numerals designate like elements.

FIG. 1A is a top view of a first embodiment of a clip including aplurality of tines in a planar orientation, in accordance with thepresent invention;

FIGS. 1B and 1C are side views of half of the clip of FIG. 1A, with thetines oriented substantially transversely from the planar orientation,in compressed and expanded states, respectively;

FIG. 1D is a top view of an alternative embodiment of a clip in a planarorientation based on the clip of FIG. 1A;

FIG. 2A is a top view of a second embodiment of a clip including aplurality of tines in a planar orientation, in accordance with thepresent invention;

FIGS. 2B and 2C are side views of half of the clip of FIG. 2A, with thetines oriented substantially transversely from the planar orientation,in compressed and expanded states, respectively;

FIG. 2D is a top view of an alternative embodiment of a clip in a planarorientation based on the clip of FIG. 2A;

FIG. 3A is a top view of a third embodiment of a clip including aplurality of tines in a planar orientation, in accordance with thepresent invention;

FIGS. 3B and 3C are side views of a third of the clip of FIG. 3A, withthe tines oriented substantially transversely from the planarorientation, in compressed and expanded states, respectively;

FIG. 3D is a top view of an alternative embodiment of a clip in a planarorientation based on the clip of FIG. 3A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used in the specification and appended claims, directional terms,such as “top,” “bottom,” “up,” “down,” “upper,” “lower,” “proximal,”“distal,” and the like are used herein solely to indicate relativedirections in viewing the drawings and are not intended to limit thescope of the claims in any way.

The present disclosure provides methods and apparatuses that aresuitable for closure of vascular punctures or other openings in bodilytissues. Generally, the apparatuses and methods described herein can beused with any type of body tissue that has sufficient strength to beheld together by the clips described hereinafter. By way of exampleonly, embodiments of the present invention can be used to close openingsin tissues that have a wall or membrane function, e.g, pulmonary,intestinal, vascular, urethral, gastric, renal or other wall structures,or in membranes, e.g., amniotic or pericardial membranes. Openings inother types of tissues can also be closed using embodiments of thepresent invention. Although many types of body tissue can be closed bythe methods and apparatuses disclosed herein, the description includedherein refers to “vessels” for convenience.

Clips according to embodiments of the present invention are useful forengaging tissue so as to connect tissue segments together or to closeand/or seal openings through tissue such as a puncture wound in a bodylumen. The clips may be used by deforming them from their generallyplanar configuration such that the tines are pointing in a directiongenerally transverse to the plane, holding the clip in this deformedcondition, deploying the clip proximal to the tissue to be engaged andremoving the deforming force such that the clip engages the tissue andattempts to return to its original generally planar configuration.Methods and delivery devices disclosed in U.S. Pat. Nos. 6,623,510 and6,719,777, which patents are incorporated herein by specific reference,can be used to deploy the clips of the present invention to engagetissue and close or seal an opening.

Turning now to the drawings, FIGS. 1A-1C show a first embodiment of aclosure device or clip 100 for closing an incision, puncture, or otherpassage through tissue, such as, e.g., communicating with a blood vesselor other body lumen. Clip 100 includes a body 102, which may begenerally annular in shape and surrounds a central axis 104, and aplurality of tissue engaging members or tines 106 extending from body102. As used herein, an “annular-shaped body” includes any hollow body,e.g., including one or more structures surrounding an opening, whetherthe body is substantially flat or has a significant thickness or depth.Thus, although an annular-shaped body may be circular, it may includeother noncircular shapes as well, such as elliptical or other shapesthat are asymmetrical about a central axis.

Body 102 may include a plurality of looped or curved elements 108 thatare connected to one another to form body 102. Each looped element 108may include an inner or first curved region 110 and an outer or secondcurved region 112. In one embodiment, inner and outer curved regions 110and 112 may be out of phase with one another and connected alternatelyto one another, thereby defining an endless substantially sinusoidalpattern. Alternatively, other generally zigzag patterns may be providedthat repeat periodically, such as, e.g., saw tooth or square toothpatterns, instead of a sinusoidal pattern, thereby defining inner andouter regions that alternate about the body 102. The zigzag pattern maybe symmetrical or asymmetrical. When clip 100 is in a substantiallyplanar configuration, as shown in FIG. 1A, inner curved regions 110 maydefine an inner periphery 114 of body 102 and clip 100, and outer curvedregions 112 may define an outer periphery 116.

As a result of the periodically repeating pattern, looped elements 108may bound inwardly facing cavities 118 and outwardly facing cavities120. Each inwardly facing cavity 118 may be bounded by one of the outercurved regions 112 and may have a mouth 122 at inner periphery 114 thatis bounded by adjacent inner curved regions 110. For example, in theembodiment shown in FIG. 1A, inwardly facing cavity 118 a is bounded byouter curved region 112 a, and corresponding mouth 122 a is bounded byadjacent inner curved regions 110 a and 110 b.

Conversely, each outwardly facing cavity 120 may be bounded by one ofthe inner curved regions 110 and may have a mouth 124 at outer periphery116 that is bounded by adjacent outer curved regions 112. For example,in the embodiment shown in FIG. 1A, outwardly facing cavity 120 a isbounded by outer curved region 110 b, and corresponding mouth 124 a isbounded by adjacent outer curved regions 112 a and 112 b.

Inwardly and outwardly facing cavities 118 and 120 may be substantiallysymmetrical or asymmetrical. Furthermore, inwardly facing cavities 118may be radially positioned about central axis 104 in the planarconfiguration so that each directly faces central axis 104, as in thedepicted embodiment. In other embodiments, one or more inwardly facingcavities may be radially positioned about central axis 104 so as to notdirectly face central axis 104, as discussed below.

Each tine 106 may extend from a corresponding outer curved region 112 toa spaced apart tip 126 and may be biased to extend generally inwardly,e.g., towards one another and/or generally towards central axis 104 whenclip 100 is in the planar configuration. Each tine 106 may extendthrough the inwardly facing cavity 118 and mouth 122 corresponding tothe outer curved region 112 from which the tine extends. As such, eachtine 106 may extend through inner periphery 114 when clip 100 is in theplanar configuration. Tines 106 may be provided in pairs opposite fromone another or may be provided otherwise symmetrically or asymmetricallywith respect to central axis 104.

Tines 106 may include a variety of pointed tips 126, such as, e.g., abayonet tip, and/or may include barbs for penetrating or otherwiseengaging tissue. For example, to increase the penetration ability ofclip 100 and/or to lower the insertion force required to penetratetissue, each tine 106 may include a tapered edge extending towards tip126 along one side of tine 106. Alternatively, each tine 106 may beprovided with a tapered edge on each side of the tine 106 extendingtowards the tip.

Tines 106 may be disposed on every outer curved region 112, as in theembodiment depicted in FIG. 1A, or on alternating outer curved regions112 (see, e.g., FIG. 1D). Other patterns of disposition can also beused. Thus, at least one period of a zigzag pattern may be disposedbetween adjacent tines 106, which may enhance flexibility of clip 100.

FIGS. 1B and 1C show a body segment 128 that represents half of clip 100in compressed and expanded states, respectively. In this configuration,one end 130 of body segment 128 may connect to or be integrally formedwith the opposite end 132 of another similar body segment 128 such thattwo connected body segments 128 may form body 102.

As shown in FIGS. 1B and 1C, body 102 and/or tines 106 may be deflectedsuch that tines 106 extend transversely with respect to the planedefined in the planar configuration, thereby defining a transverseconfiguration for clip 100. Tines 106 may be oriented substantiallyparallel to central axis 104 in the transverse configuration, as shownin FIG. 1B. In the transverse configuration, body 102 may have agenerally annular shape defining a length, L₁, that extends generallyparallel to central axis 104, and corresponds generally to an amplitudeof the zigzag pattern. Body 102 may be sufficiently flexible such thatclip 100 may assume a generally circular or elliptical shape. This mayhelp, e.g., in clip 100 conforming to an exterior surface of a deliverydevice used to deliver the clip 100. As noted above, examples of suchdelivery devices can be found in the aforementioned U.S. Pat. Nos.6,623,510 and 6,719,777.

Tines 106 and/or body 102 may be biased to move from the transverseconfiguration of FIG. 1B towards the planar configuration of FIG. 1A.Thus, with tines 106 in the transverse configuration, tines 106 maypenetrate and/or be engaged with tissue at a puncture site. When clip100 is released, tines 106 may attempt to return towards one another asclip 100 moves towards the planar configuration, thereby drawing theengaged tissue together and substantially closing and/or sealing thepuncture site. Because tines 106 extend from outer curved regions 112, apotentially wider area of the tissue around the puncture site can beengaged by the tines than when the tines are positioned on the innercurved regions 110. Furthermore, more tissue can be engaged by each tineand the tines may penetrate deeper into the tissue due to the longertine length and the extension from the outer curved regions.

Looped elements 108 may distribute stresses in clip 100 as the clip isdeformed between the planar and transverse configurations, therebyminimizing localized stresses that may otherwise plastically deform,break, or otherwise damage clip 100 during delivery. In addition, whenclip 100 is in the transverse configuration, looped elements 108 may bemovable between a compressed state, such as that shown in FIG. 1B, andan expanded state, such as that shown in FIG. 1C. In some embodiments,looped elements 108 are biased towards the expanded state, but may becompressed to the compressed state, e.g., by constraining clip 100 bymeans of a suitable delivery device (not shown). Alternatively, only aportion of looped elements 108 may be biased towards the expanded state,e.g., the inner curved regions 110, and/or looped elements 108 may bebiased towards the compressed state. Furthermore, looped elements 108may reduce the force required to be exerted on clip 100 to cause clip100 to transition from the planar configuration to the transverseconfiguration before loading onto a delivery device. The manner in whichclips can be moved between the expanded and compressed states and theadvantages of doing so is disclosed in the aforementioned U.S. Pat. Nos.6,623,510 and 6,719,777.

FIG. 1D depicts an alternative embodiment of a clip 100′ in a planarorientation based on clip 100 of FIG. 1A. While clip 100 has six loopedelements 108 and six tines 106, clip 100′ has nine looped elements 108and only three tines 106. More or less numbers of looped elements 108and/or tines 106 may alternatively be used. Furthermore, in clip 100,every outer curved region 112 has a tine 106 extending therefrom,whereas in clip 100′, tines 106 extend from every third outer curvedregion 112. That is, there may be one or more outer curved regions 112that do not include tines and that separate adjacent tines 160.

In addition, as shown in FIG. 1D, one or more secondary tines 134 mayextend from inner curved regions 110. Similar to tines 106, secondarytines 134 may be oriented generally towards central axis 104 in theplanar configuration, and generally parallel to central axis 104 in thetransverse configuration. Furthermore, similar to tines 106, each ofsecondary tines 134 may include a variety of known pointed tips, asdiscussed above. Secondary tines 134 may be shorter than tines 106. Assuch, with clip 100 in the transverse configuration, clip 100 may bedelivered such that tines 106 entirely penetrate the wall of a bloodvessel or other body lumen, while secondary tines 134 only partiallypenetrate the wall due to their relative lengths.

To manufacture clip 100 (or, similarly, any of the other clips describedherein), body 102 and tines 106 may be integrally formed from a singlesheet of material, e.g., a superelastic alloy, such as a nickel-titaniumalloy (“Nitinol”). Portions of the sheet may be removed usingconventional methods, such as laser cutting, chemical etching, photochemical etching, stamping, using an electrical discharge machine (EDM),and the like, to form the clip. Clip 100 may be manufactured in anexpanded oversize planar configuration to provide space for removingmaterial and/or to allow for overlapping of tines, which method isdisclosed in PCT Application US03/40812, which was filed on Dec. 17,2003 and which is herein incorporated by specific reference in itsentirety. Tines 106 (and/or secondary tines 134, if used) may besharpened to a point, e.g., tips 126 may be formed on tines 106, usingconventional methods, such as chemical etching, mechanical grinding, andthe like.

Clip 100 may be polished to a desired finish using conventional methods,such as electro-polishing, chemical etching, tumbling, sandblasting,sanding, and the like. Polishing may perform various functions dependingon the method used to form clip 100. For a clip formed by laser cuttingor using an EDM, polishing may remove heat affected zones (HAZ) and/orburrs from the clip. For a clip formed by photo chemical etching,polishing may create a smoother surface finish. For a clip formed bystamping, polishing may remove or reduce burrs from the bottom side ofthe clip, and/or may smooth the “roll” that may result on the topside ofthe clip from the stamping process.

In addition or alternatively, clip 100 may be formed from a shape memoryalloy, e.g., Nitinol, with looped elements 108 formed initially in thecompressed state and/or clip 100 in the planar configuration. With clip100 deformed to the transverse configuration, the clip 100 may beexpanded, e.g., by applying a force radially outwards against an innersurface of clip 100, thereby expanding the looped elements 108 to theexpanded state. Looped elements 108 may then be heat treated, e.g., byheating clip 100 to an austenitic state, to cause looped elements 108 to“remember” the expanded state, as is known to those skilled in the art.It may also be necessary to further heat treat clip 100 further, e.g.,with the tines in the planar configuration to cause body 102 and/ortines 106 to “remember” and be biased towards the planar configuration,as is known to those skilled in the art. Clip 100 may then be cooled,e.g., to a martensitic state, which may be at or close to ambienttemperature, and manipulated, e.g., malleably deformed to the transverseconfiguration, for example, by loading clip 100 onto a delivery device.Thus, if clip 100 is subsequently heated to a predetermined temperature,e.g., at or below body temperature, the material may remember the planarconfiguration and/or expanded state and become biased towards them.

FIGS. 2A-2C show a second embodiment of a closure device or clip 200.The reference numbers for elements of clip 200 are consistent with likeelements used for clip 100.

In many commercial applications, a guide wire is used to help position aclip prior to closing an opening in a tissue. The guide wire may beretracted from the tissue as the clip moves from the transversalconfiguration to the planar configuration. As such, the guide wire isgenerally pushed to the middle (i.e., to the central axis) of the clipas the guide wire is removed. In many conventional clips, the guide wiremay snag on one of the tines of the clip as the guide wire is refracted,which can cause various problems and may require additional work toremove the guide wire from the tines. In many cases the entire clip mayneed to be removed and replaced. Clip 200 may ameliorate this problem,as discussed below.

Clip 200 includes a generally annular-shaped body 202 defining a planeand disposed about a central axis 204 extending through the plane, and aplurality of tissue engaging members or tines 206 extending from body202. Body 202 may include a plurality of looped elements 208 that areconnected to one another to form body 202, similar to the previousembodiment. Each looped element 208 may include an inner curved region210 and an outer curved region 212. Similar to the previous embodiment,inner and outer curved regions 210 and 212 may form an endlesssubstantially sinusoidal pattern or other generally zigzag pattern. Whenclip 200 is in a substantially planar configuration, as shown in FIG.2A, inner curved regions 210 may define an inner periphery 214 of clip200, and outer curved regions 212 may define an outer periphery 216 ofclip 200.

Looped elements 208 may bound inwardly facing cavities 218 and outwardlyfacing cavities 220, similar to the previous embodiment. That is, eachinwardly facing cavity 218 may be bounded by one of the outer curvedregions 212 and may have a mouth 222 at inner periphery 214 that isbounded by adjacent inner curved regions 210. Similarly, each outwardlyfacing cavity 220 may be bounded by one of the inner curved regions 210and may have a mouth 224 at outer periphery 216 that is bounded byadjacent outer curved regions 212.

One or more of the inwardly facing cavities 218 may be radiallypositioned about central axis 204 in the planar configuration so as toface a direction that does not pass through central axis 204. That is,one or more inwardly facing cavities (denoted 218′) may be offset so asto open up to one side or the other of central axis 204. For example,FIG. 2A depicts a number of inwardly facing cavities 218′ that areformed so as to face directions that do not pass through central axis204.

Similar to the previous embodiment, each tine 206 may extend from acorresponding outer curved region 212 to a spaced apart tip 226 and maybe biased to extend generally inwardly, e.g., towards one another whenclip 200 is in the planar configuration. Each tine 206 may extend froman outer curved region 212 through an offset inwardly facing cavity 218′in a direction that does not pass through, i.e., is offset from, centralaxis 204. Tines 206 may or may not face substantially the same directionas inwardly facing cavity 218′. By facing a direction that does not passthrough central axis 204, tines 206 may extend beyond central axis 204without passing therethrough. Tines 206 may also be configured to extendbeyond central axis 204 without overlapping or otherwise contacting eachother. As a result, an open central lumen about central axis 204 may becollectively formed by tines 206.

For example, in the embodiment of FIG. 2A, each tine 206 extends from acorresponding outer curved region 212, through a corresponding offsetcavity 218′ in a direction that does not pass through central axis 204and into a central region 236 bounded by inner periphery 214. Each tine206 may be configured to be offset from central axis 204 a predeterminedamount so as to be able to extend a predetermined distance to the sideof central axis 204. Each of tines 206 can be configured to be offsetthe same amount or different amounts from central axis 204. For example,each tine 206 may form an angle α with respect to a radial thatintersects central axis 204 that is between about 1 degree to about 20degrees, with about 6 degrees to about 15 degrees being common. Otherangles may alternatively be used.

As shown in FIG. 2A, tines 206 can be configured to extend beyondcentral axis 204 toward, but not overlap adjacent tines 206. In thismanner, distal ends 238 of tines 206 can collectively bound an opencentral lumen 240 about central axis 204. Using a bounded open centrallumen may result in a better closure of a tissue opening because acomplete closure of the opening can be obtained in the planarconfiguration. Furthermore, because tines 206 are angled away fromcentral lumen 240, a guide wire, if used, may freely pass by (i.e., notsnag on) any of the offset tines 206 as the guide wire is retracted fromthe opening.

Although depicted as not overlapping, it is appreciated that one or moretines 206 can alternatively overlap each other, if desired, as discussedbelow.

Similar to the previous embodiment, tines 206 may include a variety ofpointed tips and/or barbs, as discussed above. Furthermore, tines 206may be disposed on every outer curved region 212 or on alternating outercurved regions 212. Other patterns of disposition can also be used.

FIGS. 2B and 2C show a body segment 228 that represents half of clip 200in compressed and expanded states, respectively, similar to the priorembodiment. In this configuration, one end 230 of body segment 228 mayconnect to or be integrally formed with the opposite end 232 of anothersimilar body segment 228 such that two connected body segments 228 mayform body 202.

As shown in FIGS. 2B and 2C, body 202 and/or tines 206 may be deflectedsuch that tines 206 extend transversely with respect to the planedefined in the planar configuration, thereby defining a transverseconfiguration for clip 200. As shown in FIG. 2B, tines 206 can be offsetfrom central axis 204 so as to be non-collinear therewith in thetransverse configuration. However, although tines 206 may not becollinear with central axis 204, tines 206 may lie within a plane thatis oriented generally parallel to central axis 204 in the transverseconfiguration.

FIG. 2D depicts an alternative embodiment of a clip 200′ in a planarorientation based on clip 200 of FIG. 2A. While clip 200 has six loopedelements, clip 200′ has nine looped elements. More or less numbers oflooped elements 208 may alternatively be used. In addition, similar tothe previous embodiment, one or more secondary tines 234 having similarcharacteristics as secondary tines 134 may extend from inner curvedregions 210. Furthermore, while tines 206 extend through inwardly facingcavities 118′ that are offset in clip 200, tines 206 extend throughinwardly facing cavities 118 that are not offset in clip 200′. As aresult, each tine 206 may be closer to one of the adjacent inner curvedregions 210 that bound the corresponding mouth 222 than to the other ofthe adjacent inner curved regions 210 that bound the mouth 222. Forexample, in FIG. 2D, tine 206 a is closer to inner curved region 210 athan to inner curved region 102 b that bound mouth 222 a. In addition,tines 206 may overlap each other to form central lumen 240, as shown inFIG. 2D. Overlapping of tines 206 may cause the tissue to overlap,thereby providing a possibly better closure. For embodiments describedherein in which two or more of the tines overlap, the closure device canbe manufactured in an expanded planar sized configuration or acylindrical configuration using a heat treating or setting process, asdiscussed above, to cause the closure device to bias towards the planarstate in which the tines overlap.

FIGS. 3A-3C show a third embodiment of a closure device or clip 300wherein the tines overlap to form a central region. The referencenumbers for elements of clip 300 are consistent with like elements usedfor clips 100 and 200. Similar to the previous embodiments, clip 300includes a generally annular-shaped body 302 defining a plane anddisposed about a central axis 304 extending through the plane, and aplurality of tissue engaging members or tines 306 extending from body302. Body 302 may include a plurality of looped elements 308 that areconnected to one another to form body 302, similar to the previousembodiments. Each looped element 308 may include an inner curved region310 and an outer curved region 312. Similar to the previous embodiment,inner and outer curved regions 310 and 312 may form an endlesssubstantially sinusoidal pattern or other generally zigzag pattern.

When clip 300 is in a substantially planar configuration, as shown inFIG. 3A, inner curved regions 310 may define an inner periphery 314 ofclip 300, and outer curved regions 312 may define an outer periphery 316of clip 300. However, in contrast to the previous embodiments, one ormore of the inner curved regions 310 may be recessed towards outerperiphery 316 so as to not be used in defining inner periphery 314. Thatis, one or more inner curved regions 310 may not extend to innerperiphery 314. For example, in FIG. 3A inner curved regions 310′ are notused to define inner periphery 314.

Looped elements 308 may bound inwardly facing cavities 318 and outwardlyfacing cavities 320, similar to the previous embodiments. That is, eachinwardly facing cavity 318 may be bounded by one of the outer curvedregions 312 and may have a mouth 322 at inner periphery 314 that isbounded by adjacent inner curved regions 310. Similarly, each outwardlyfacing cavity 320 may be bounded by one of the inner curved regions 310and may have a mouth 324 at outer periphery 316 that is bounded byadjacent outer curved regions 312.

Similar to the second embodiment, one or more of the inwardly facingcavities (denoted 318′) may face a direction that does not pass throughcentral axis 304. That is, one or more inwardly facing cavities 318′ maybe offset so as to open up to one side or the other of central axis 304.Furthermore, one or more of the offset inwardly facing cavities 318′ canbe paired with an opposing offset inwardly facing cavity 318′ such thatboth cavities “point” towards each other. For example, inwardly facingcavities 318 a′ and 318 b′ are configured to face a direction that doesnot pass through central axis 204, yet point towards each other onopposite sides of body 302.

Similar to the previous embodiments, each tine 306 may extend from acorresponding outer curved region 312 to a spaced apart tip 326 and maybe biased to extend generally inwardly, e.g., towards one another whenclip 300 is in the planar configuration. Similar to the secondembodiment, discussed above, each tine 306 may extend from an outercurved region 312 through an offset inwardly facing cavity 318′ and intoa central region 336 bounded by inner periphery 314 so as extend in adirection that does not pass through i.e., is offset from, central axis304. This may allow tines 306 to extend beyond central axis 304 withoutpassing therethrough so as to collectively bound an open central lumen340 about central axis 304, similar to the previous embodiment. Eachtine 306 may form an angle α with respect to a radial that intersectscentral axis 304 in similar ranges as discussed with regard to thesecond embodiment.

As shown in FIG. 3A, tines 306 may extend beyond central axis 304 so asto overlap each other. Furthermore, one or more tines 306 may extendcompletely through central region 336 so that each tip 326 may extendinto a corresponding paired inwardly facing cavity 318′ positioned on anopposite side of body 302 as the inwardly facing cavity 318′ from whichtine 306 extends. For example, in FIG. 3A, tine 306 a extends from outercurved region 312 a, through inwardly facing cavity 318 a′, completelythrough central region 336 and into opposing inwardly facing cavity 318b′. Overlapping tines 306 may provide a better closure thannon-overlapping tines. Furthermore, the extension of tines into opposinginwardly facing cavities may cause the tissue to compress against theopposing inwardly facing cavities when clip 300 is moved to the planarconfiguration, thereby causing tighter and more secure closure.

Similar to the previous embodiment, tines 306 may include a variety ofpointed tips and/or barbs, as discussed above.

FIGS. 3B and 3C show a body segment 328 that represents a third of clip300 in compressed and expanded states, respectively. In thisconfiguration, one end 330 of body segment 328 may connect to or beintegrally formed with the opposite end 332 of another similar bodysegment 328 such that three connected body segments 328, sequentiallyconnected, may form body 302.

As shown in FIGS. 3B and 3C, body 302 and/or tines 306 may be deflectedsuch that tines 306 extend transversely with respect to the planedefined in the planar configuration, thereby defining a transverseconfiguration for clip 300. As shown in FIG. 3B, tines 306 can be offsetfrom central axis 304 so as to be non-collinear therewith in thetransverse configuration. However, although tines 306 may not becollinear with central axis 304, tines 306 may lie within a plane thatis oriented generally parallel to central axis 304 in the transverseconfiguration.

FIG. 3D depicts an alternative embodiment of a clip 300′ in a planarorientation based on clip 300 of FIG. 2A. While clip 300 has nine loopedelements, clip 300′ has six looped elements. In clip 300′ the loopedelements 308 of clip 300 that include inwardly facing cavities 318through which no tines 306 pass have been removed. As a result, the onlylooped elements 308 that remain are those that include inwardly facingcavities through which a tine 306 passes. Of course more or less numbersof looped elements 208 may alternatively be used in variousconfigurations.

Furthermore, where the looped elements have been removed, the innercurved regions 310 may be positioned further inward (i.e. toward centralaxis 304) in the planar configuration so as to cause inner periphery 314to have a smaller diameter and therefore be closer to tines 306. Thismay aid in providing a more secure and effective closure action.

Clip 300 can also be modified in other ways similar to one or more ofthe previous embodiments. For example, one or more secondary tineshaving similar characteristics to those described previously may extendfrom one or more inner curved regions 310. Furthermore, tines 306 mayextend through inwardly facing cavities 318 that are not offset. Otheralternatives may also be possible.

It is appreciated that in addition to the many variations describedabove, many additional modifications to any of the inventive clips areenvisioned and encompassed by the current application. For example, theclip may include radiopaque or other markers, and/or porous surfaces topromote tissue ingrowth. Also, the clip may be coated in whole or inpart with a bioabsorbable material and/or coated with a materialcontaining a substance which is delivered to the patient fortherapeutic, diagnostic or other purposes. Such coatings may comprisepeptides, clotting factors or other materials designed to benefit thepatient. Also, any of the tines associated with any particular clip maybe of equal length and shape or may be of differing lengths and/orshapes. In addition, although depicted as being substantially straight,any of the tines described herein can alternatively be curved orarcuately shaped. Other tine shapes are also possible. Stop members orspring elements, as described in the aforementioned U.S. Pat. No.6,623,510 may also be used with the clip.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

What is claimed is:
 1. A device for engaging tissue, comprising: agenerally annular-shaped body defining a plane and disposed about acentral axis extending substantially normal to the plane, the body beingmovable from a substantially planar configuration lying generally in theplane towards a transverse configuration extending out of the plane, thebody comprising: a plurality of looped elements comprising alternatinginner and outer curved regions, the inner curved regions defining aninner periphery of the body and the outer curved regions defining anouter periphery of the body in the planar configuration, each innercurved region forming an outwardly facing cavity and each outer curvedregion forming an inwardly facing cavity; and a plurality of tinesextending from the outer curved regions, each tine extending from a baseof the inwardly facing cavity and being spaced apart from a remainder ofthe outer curved region and the inner curved region, the tines beingoriented generally towards the central axis in the planar configuration,and generally parallel to the central axis in the transverseconfiguration.
 2. The device of claim 1, wherein the body is biasedtowards the planar configuration for biasing the tines generally towardsthe central axis.
 3. The device of claim 1, wherein the looped elementsgenerally define an endless zigzag pattern extending about the centralaxis.
 4. The device of claim 1, wherein the plurality of looped elementsare movable between expanded and compressed states for increasing andreducing, respectively, a periphery of the body in the transverseorientation.
 5. The device of claim 4, wherein the plurality of loopedelements are biased towards the compressed state.
 6. The device of claim1, further comprising one or more secondary tines extending from theinner curved regions, the secondary tines being oriented generallytowards the central axis in the planar configuration, and generallyparallel to the central axis in the transverse configuration.
 7. Thedevice of claim 1, wherein at least one of the tines extends through theinner periphery in the planar configuration.
 8. The device of claim 1,wherein the inner periphery bounds a central region through which thecentral axis extends in the planar configuration, and at least one ofthe tines extends into the central region.
 9. A device for engagingtissue, comprising: a generally annular-shaped body defining a plane anddisposed about a central axis extending substantially normal to theplane, the body being movable from a substantially planar configurationlying generally in the plane towards a transverse configurationextending out of the plane, the body comprising: a plurality of loopedelements comprising alternating inner and outer curved regions, theinner curved regions defining an inner periphery of the body and theouter curved regions defining an outer periphery of the body in theplanar configuration, each inner curved region forming an outwardlyfacing cavity having an inner curved region base and an inner curvedregion opening open to the outer periphery of the body and each outercurved region forming an inwardly facing cavity and having an outercurved region base and an outer curved region opening open to the innerperiphery of the body; and a plurality of tines extending from the outercurved regions, each tine extending from the outer curved region base ofthe inwardly facing cavity and being spaced apart from a remainder ofthe outer curved region and the inner curved region, the tines beingoriented toward the inner periphery in the planar configuration, eachtine extending beyond the central axis and through at least a portion ofthe inwardly facing cavity without passing through the central axis soas to collectively form a central lumen about the central axis in theplanar configuration, the tines being oriented generally parallel to thecentral axis in the transverse configuration.
 10. The device of claim 9,wherein the tines at least partially overlap each other in the planarconfiguration.
 11. The device of claim 9, wherein at least one tineextends completely through an opposite side of the inner periphery inthe planar configuration.
 12. The device of claim 9, wherein at leastone tine extends through one of the inwardly facing cavities and intoanother of the inwardly facing cavities in the planar configuration. 13.The device of claim 9, wherein at least one tine extends from one of theouter curved regions on one side of the body through the inner peripheryand into a corresponding inwardly facing cavity on an opposite side ofthe body in the planar configuration.
 14. The device of claim 9, whereinat least one looped element bounds the inwardly facing cavity that facesa direction that does not pass through the central axis in the planarconfiguration.
 15. The device of claim 14, wherein one of the tinesextends through the inwardly facing cavity in substantially the samedirection as the inwardly facing cavity so as to not pass through thecentral axis in the planar configuration.
 16. The device of claim 9,wherein the looped elements generally define an endless zigzag patternextending about the central axis.
 17. The device of claim 16, whereinthe zigzag pattern is asymmetrical.
 18. The device of claim 9, whereinthe inwardly facing cavities having a mouth bounded on either side byadjacent inner curved regions, and wherein each tine extends through acorresponding mouth.
 19. The device of claim 18, wherein each tine iscloser to one of the adjacent inner curved regions that bound thecorresponding mouth than to the other of the adjacent inner curvedregions that bound the corresponding mouth.
 20. The device of claim 9,further comprising one or more secondary tines extending from the innercurved regions, the secondary tines being oriented generally towards thecentral axis in the planar configuration, and generally parallel to thecentral axis in the transverse configuration.
 21. A device for engagingtissue, comprising: a generally annular-shaped body defining a plane anddisposed about a central axis extending substantially normal to theplane, the body being movable from a substantially planar configurationlying generally in the plane towards a transverse configurationextending out of the plane, the body comprising: a plurality of loopedelements comprising alternating inner and outer curved regions, theinner curved regions defining an inner periphery of the body and theouter curved regions defining an outer periphery of the body in theplanar configuration, each inner curved region forming an outwardlyfacing cavity and each outer curved region forming an inwardly facingcavity; and a plurality of tines extending from the outer curvedregions, the tines being oriented toward the inner periphery in theplanar configuration, each tine extending beyond the central axis andthrough at least a portion of the inwardly facing cavity without passingthrough the central axis so as to collectively form a central lumenabout the central axis in the planar configuration, the tines beingoriented generally parallel to the central axis in the transverseconfiguration, wherein the tines at least partially overlap each otherin the planar configuration.
 22. The device of claim 21, wherein atleast one tine extends completely through an opposite side of the innerperiphery in the planar configuration.
 23. The device of claim 21,wherein at least one tine extends through one of the inwardly facingcavities and into another of the inwardly facing cavities in the planarconfiguration.
 24. The device of claim 21, wherein at least one tineextends from one of the outer curved regions on one side of the bodythrough the inner periphery and into a corresponding inwardly facingcavity on an opposite side of the body in the planar configuration. 25.The device of claim 21, wherein at least one looped element bounds theinwardly facing cavity that faces a direction that does not pass throughthe central axis in the planar configuration.
 26. The device of claim25, wherein one of the tines extends through the inwardly facing cavityin substantially the same direction as the inwardly facing cavity so asto not pass through the central axis in the planar configuration. 27.The device of claim 21, wherein the looped elements generally define anendless zigzag pattern extending about the central axis.
 28. The deviceof claim 27, wherein the zigzag pattern is asymmetrical.
 29. The deviceof claim 21, wherein the inwardly facing cavities having a mouth boundedon either side by adjacent inner curved regions, and wherein each tineextends through a corresponding mouth.
 30. The device of claim 29,wherein each tine is closer to one of the adjacent inner curved regionsthat bound the corresponding mouth than to the other of the adjacentinner curved regions that bound the corresponding mouth.